You’ve submitted your Investigational New Drug (IND) to the FDA, you’ve developed the investigator brochure and you have identified investigational sites or a phase who is willing to conduct your phase 1 study. Of course, you’ve double checked with the investigators to make certain that they have eligible healthy volunteers or patients to be enrolled. Lastly, the investigators have been involved at some point in the development of the clinical protocol.
You have approval from the FDA and investigative site IRB’s. Your phase 1 clinical study appears to be ready to start. Phase 1 clinical studies seem to be very straight forward and simple because after all, they are small and you are dose escalating looking for that safe and efficacious dose to move on to the next stage of development. Safety is paramount in early stage studies. Safety issues discussed on the front page of popular newspapers and by Fierce Biotech or if the FDA puts you on a “CLINICAL HOLD” it’s not the attention you want. Many drugs that undergo preclinical (animal) testing never even make it to human testing but you made it to Phase 1, so be proactive and manage what you can.
There are some safety issues that are out of your control but as you would agree, there are some that you can managed up front. First, putting together a cross functional team at least consisting of scientists, pharmacologist, pharmacovigilance specialists, regulatory specialists and of course, the Medical Monitor is pretty important. In my opinion, many biotech/Pharma are focused on moving rapidly through phase 1 so that they can get to the later stages of development as soon as possible. I understand that the need to move forward rapidly due to competition does figure into the equation and moving rapidly may be a directive from senior management but closely reviewing the data and exchanging data-information with the investigators before moving to the next dose level is prudent. You should always ask, do the benefits outweigh the risks?
The use of EDC allows you to have immediate access to the data once it is entered by the clinical staff at the investigative staff. That being said, it is important to identify someone internally (Sponsor/Sponsor representative) to review the data and managed the investigative sites regarding timely data entry and timely resolution of data queries.
This is a very streamlined approach of how to move forward in early stage drug development but it’s by no means the “process”, it may be beneficial to review the FDA’s drug review process if you are new to drug development http://alturl.com/j4s89